Cardiac RadiothErapy For hEart faiLure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).
Objective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.
Main study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).
Eligibility criteria
Qualifiers
Patient ≥ 18 years
Advanced refractory HF NYHA class II, III or IV
Stable HF for the last 6 months with maximal guideline-directed HF therapy
Ischemic or dilated cardiomyopathy
Disqualifiers
Eligible or in consideration for heart transplantation
Pregnancy or breastfeeding
Previous radiotherapy with cardiac involvement
Any condition that is deemed a contraindication in the judgment of the investigators
Trial design
Treatments tested in this trial
- 5 Gray Whole Heart external beam radiotherapy
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov